{
    "info": {
        "nct_id": "NCT01680172",
        "official_title": "Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer",
        "inclusion_criteria": "* Patients with cancer\n* Outpatient status at the time of study entry\n* 18 years of age or older\n* Life expectancy of at least 1 month\n* Regular access to a telephone (for safety reasons)\n* Reliable transportation to follow-up visits\n* Caregiver observation available for 24 hours after the dose\n* Histologically-proven malignancy\n* Depression score of >11 on the Hospital Anxiety and Depression Scale (HADS)\n* Provision of informed consent\n* Able to complete the patient questionnaires alone or with assistance\n* Able to speak and read English\n* May receive other psycho-active medications while on the study i.e. opiates, except as defined within the exclusion criteria\n* May receive psychotherapy from an outside provider at the beginning and/or during the course of the study\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Obvious cognitive dysfunction or Mini Mental Status Exam score <20\n* Antidepressants started or dose changed within 8 weeks of the beginning of the study or during the study\n* Benzodiazepines prescribed for psychiatric indications that have been started or dose change within 2 weeks of the beginning of study enrollment\n* Suicidal ideation or a suicide attempt within the last year\n* Patients with current or past psychosis not from delirium\n* Females who are pregnant or nursing\n* Unable to take oral medications\n* Primary or metastatic brain malignancy\n* Gastrointestinal tract obstruction\n* Prior adverse reaction to or other contraindication to ketamine\n* Substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria, within the last 90 days",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with cancer",
            "criterions": [
                {
                    "exact_snippets": "Patients with cancer",
                    "criterion": "cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Outpatient status at the time of study entry",
            "criterions": [
                {
                    "exact_snippets": "Outpatient status at the time of study entry",
                    "criterion": "outpatient status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "outpatient"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of at least 1 month",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of at least 1 month",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Regular access to a telephone (for safety reasons)",
            "criterions": [
                {
                    "exact_snippets": "Regular access to a telephone",
                    "criterion": "telephone access",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Reliable transportation to follow-up visits",
            "criterions": [
                {
                    "exact_snippets": "Reliable transportation to follow-up visits",
                    "criterion": "transportation to follow-up visits",
                    "requirements": [
                        {
                            "requirement_type": "reliability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Caregiver observation available for 24 hours after the dose",
            "criterions": [
                {
                    "exact_snippets": "Caregiver observation available",
                    "criterion": "caregiver observation",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "24 hours after the dose",
                    "criterion": "observation duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically-proven malignancy",
            "criterions": [
                {
                    "exact_snippets": "Histologically-proven malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "verification method",
                            "expected_value": "histologically-proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Depression score of >11 on the Hospital Anxiety and Depression Scale (HADS)",
            "criterions": [
                {
                    "exact_snippets": "Depression score of >11 on the Hospital Anxiety and Depression Scale (HADS)",
                    "criterion": "depression score",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "Hospital Anxiety and Depression Scale (HADS)"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 11,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provision of informed consent",
            "criterions": [
                {
                    "exact_snippets": "Provision of informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to complete the patient questionnaires alone or with assistance",
            "criterions": [
                {
                    "exact_snippets": "Able to complete the patient questionnaires alone or with assistance",
                    "criterion": "ability to complete patient questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "assistance",
                            "expected_value": [
                                "alone",
                                "with assistance"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to speak and read English",
            "criterions": [
                {
                    "exact_snippets": "Able to speak and read English",
                    "criterion": "English language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": [
                                "speak",
                                "read"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* May receive other psycho-active medications while on the study i.e. opiates, except as defined within the exclusion criteria",
            "criterions": [
                {
                    "exact_snippets": "May receive other psycho-active medications",
                    "criterion": "psycho-active medications",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "opiates",
                    "criterion": "opiates",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* May receive psychotherapy from an outside provider at the beginning and/or during the course of the study",
            "criterions": [
                {
                    "exact_snippets": "May receive psychotherapy from an outside provider",
                    "criterion": "psychotherapy",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": "outside provider"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Obvious cognitive dysfunction or Mini Mental Status Exam score <20",
            "criterions": [
                {
                    "exact_snippets": "Obvious cognitive dysfunction",
                    "criterion": "cognitive dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Mini Mental Status Exam score <20",
                    "criterion": "Mini Mental Status Exam score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Benzodiazepines prescribed for psychiatric indications that have been started or dose change within 2 weeks of the beginning of study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Benzodiazepines prescribed for psychiatric indications",
                    "criterion": "benzodiazepines prescription",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "psychiatric"
                        }
                    ]
                },
                {
                    "exact_snippets": "Benzodiazepines ... started or dose change within 2 weeks of the beginning of study enrollment",
                    "criterion": "benzodiazepines prescription",
                    "requirements": [
                        {
                            "requirement_type": "start or dose change timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suicidal ideation or a suicide attempt within the last year",
            "criterions": [
                {
                    "exact_snippets": "Suicidal ideation",
                    "criterion": "suicidal ideation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "a suicide attempt within the last year",
                    "criterion": "suicide attempt",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with current or past psychosis not from delirium",
            "criterions": [
                {
                    "exact_snippets": "Patients with current or past psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not from delirium",
                    "criterion": "delirium",
                    "requirements": [
                        {
                            "requirement_type": "origin",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females who are pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Females who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Females who are ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to take oral medications",
            "criterions": [
                {
                    "exact_snippets": "Unable to take oral medications",
                    "criterion": "ability to take oral medications",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary or metastatic brain malignancy",
            "criterions": [
                {
                    "exact_snippets": "Primary ... brain malignancy",
                    "criterion": "primary brain malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic brain malignancy",
                    "criterion": "metastatic brain malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gastrointestinal tract obstruction",
            "criterions": [
                {
                    "exact_snippets": "Gastrointestinal tract obstruction",
                    "criterion": "gastrointestinal tract obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior adverse reaction to or other contraindication to ketamine",
            "criterions": [
                {
                    "exact_snippets": "Prior adverse reaction to ... ketamine",
                    "criterion": "adverse reaction to ketamine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindication to ketamine",
                    "criterion": "contraindication to ketamine",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria, within the last 90 days",
            "criterions": [
                {
                    "exact_snippets": "Substance abuse or dependence, as defined by Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria, within the last 90 days",
                    "criterion": "substance abuse or dependence",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Antidepressants started or dose changed within 8 weeks of the beginning of the study or during the study",
            "criterions": [
                {
                    "exact_snippets": "Antidepressants started or dose changed within 8 weeks of the beginning of the study",
                    "criterion": "antidepressant use",
                    "requirements": [
                        {
                            "requirement_type": "start time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "dose change time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "antidepressants ... during the study",
                    "criterion": "antidepressant use",
                    "requirements": [
                        {
                            "requirement_type": "use during study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}